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Robotic Assessment of Lower Extremity Motor Learning

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361867
First Posted: May 27, 2011
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
Results First Submitted: April 10, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Healthy Subjects
Intervention: Device: Robot-induced perturbations

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy subjects were recruited by posting flyers in public areas and by contacting subjects who had previously expressed interest for volunteering in research studies in our laboratory.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Robot-induced Perturbations

The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.

Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations.


Participant Flow:   Overall Study
    Robot-induced Perturbations
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Robot-induced Perturbations

The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.

Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations.


Baseline Measures
   Robot-induced Perturbations 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      15 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  40.0% 
Male      9  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  13.3% 
Not Hispanic or Latino      13  86.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      15 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   15 
Step Length [1] 
[Units: Cm]
Mean (Standard Deviation)
 25.0  (0.3) 
[1] Please notice that step length was defined as the maximum value of the foot position in the anteroposterior direction in a coordinate system positioned at the center of rotation of the robotic joint connecting the pelvis and thigh components of the exoskeleton system. In other words, this measure differs from standard measures of step length during overground walking.
Step Height [1] 
[Units: Cm]
Mean (Standard Deviation)
 9.7  (0.2) 
[1] Please notice that step height was defined as the distance between the foot and the belt of the treadmill during the midswing phase of the gait cycle. This definition of step height allowed us to measure it where the effect of the perturbation led to a maximum deviation from the baseline value


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Step Length Adaptation   [ Time Frame: within a trial of the experiment (i.e. a few minutes) ]

2.  Secondary:   Step Height Adaptation   [ Time Frame: within a trial of the experiment (i.e. a few minutes) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was based on pilot experiments (N=35) aimed to determine how to use the robot to perturb step length and step height during gait. In the actual study (N=15), the investigators assessed how individuals adapted to the perturbations.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paolo Bonato
Organization: Spaulding Rehabilitation Hospital
phone: 617-952-6319
e-mail: pbonato@partners.org



Responsible Party: Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01361867     History of Changes
Other Study ID Numbers: 2009-P-002030
First Submitted: May 25, 2011
First Posted: May 27, 2011
Results First Submitted: April 10, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017